MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 16MM KNEE ENDOPROSTHETICS

Model Number NR883M

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going. Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with enduro meniscal. According to the complaint description, it was reported that fracture of axis occured. Both axis and inlay changed. The primary implantation of the prosthesis was on (b)(6) 2012 in the (b)(6). The first inlay and axis revision due to suspicion of infection was on (b)(6) 2014, the second for the same reason on (b)(6) 2017, both in (b)(6). Now the third revision on (b)(6) 2020, the axis and the inlay changed, but the existing locknut was reused. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: ENDURO MENISCAL COMPONENT F2 16MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10563903
• MDR Text Key: 208341739
• Report Number: 9610612-2020-00490
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2022
• Device Model Number: NR883M
• Device Catalogue Number: NR883M
• Device Lot Number: 52336148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/21/2020 Patient Sequence Number: 1